"In this new globalized world, we have to step outside our own borders and think in new ways," FDA Commissioner Margaret Hamburg, MD, said at Friday's public meeting soliciting input on how to implement section VII of the law.

Section VII of the law gives the FDA broad new powers to regulate the global supply chain in an era where 40% of finished products and 80% of active ingredients come from outside the U.S. -- many passing through hands that can't be accounted for. The number and variety of manufacturers, shippers, and distributors continues to grow, creating challenges for the FDA in regulating them and opportunities for criminals to introduce counterfeit drugs into the supply chain.

Friday's guidance defines the types of actions and circumstances the FDA will consider to be delaying, denying access, or limiting inspections. Doing so will have the products associated with such a facility deemed adulterated and not permitted for sale in the U.S.

"Specifically, administrative detention is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that may be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate," the proposed rule stated.

Increased penalties for people who knowingly adulterate a drug that causes adverse health consequences or death take effect later this year.

"These are the first of several new authorities under FDASIA," Hamburg said.

Others include:

Allowing further collection, analyzing, and sharing of information about manufacturers with foreign regulators

Making inspection cycles more uniform between foreign and domestic manufacturers

Advancing an inspection schedule that places more emphasise on high-risk facilities

Shifting the burden to the importer to prove the safety of a drug before it's allowed into the country rather than the FDA having to prove it's adulterated

FDA-regulated shipments to U.S. ports have quadrupled in the last decade, with the agency now overseeing 130,000 importers from 300,00 foreign facilities.

"There is no sign this trend is going to abate," Hamburg said. "In fact, we see it increasing every day."

John Taylor III, JD, acting deputy commissioner for Global Regulatory Operations and Policy, said this "staggering" increase has "eliminated distinguishing between foreign and domestic importers."

The FDA can't just be domestically focused any more, Taylor said, and has established 12 posts in 10 countries to help regulate the products that will make their way to the American drugstores.

Taylor noted cases of counterfeit or adulterated products entering the U.S., including atorvastatin (Lipitor) in 2003, heparin in 2008, and most recently bevacizumab (Avastin).

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